Five stages. A different hire at each one.

The hires at this stage are the ones that make everything downstream possible. And the ones most commonly deferred until it's too late.

Regulatory Affairs manages the relationship with the FDA, MHRA, or notified body and sets the pathway to clearance. Clinical-facing roles generate the evidence regulators and payers will both require. The Director of Clinical Adoption is the first commercial voice into the clinical environment: present before clearance exists, before a sales team is justified, building the relationships that will determine early adoption.

GTM strategy is designed here: target customer mapping, decision-making unit, channel hypothesis, early reimbursement pathway. HEOR modelling runs in parallel. Companies that design clinical trials to satisfy the regulator but not the payer achieve clearance without reimbursement. Without reimbursement, there's no revenue. Funding strategy carries commercial consequence at this stage too: Series A and B rounds, non-dilutive grants from NIH SBIR/STTR, Innovate UK, or Enterprise Ireland all shape what the commercial organisation can look like when it eventually exists.

Companies that treat reimbursement and GTM design as post-clearance problems lose twelve to eighteen months they cannot recover.

And the companies that haven't been working on those problems since Stage 01 are already behind.

In the US, the coding and coverage pathway (CPT codes, HCPCS, DRG classification) takes twelve to twenty-four months to secure. That process must be in motion before the sales team is deployed, not after the first quarter of flat performance prompts the question. In the UK, NICE MTEP submission and MedTech Funding Mandate positioning determine whether NHS adoption follows approval or stalls for years while a clinically sound product sits in a procurement queue.

In the Republic of Ireland, the equivalent pathway runs through the Health Products Regulatory Authority (HPRA) for device approval and the National Centre for Pharmacoeconomics (NCPE) for reimbursement assessment. A Market Access hire without active NCPE relationships is starting six months behind.

The hires at this stage are Market Access and Reimbursement leadership. They map the payer environment, manage the clinical dossier, and confirm the coding strategy. Territory design, incentive structure, and the profile of the first commercial hire are locked here. Launch follows a lighthouse account model: five to ten carefully selected accounts with strong clinical champions and a favourable payer mix before any broader rollout.

These decisions are hard to reverse. A sales team deployed into an unprepared reimbursement environment doesn't miss quota quietly. It burns through headcount, turns over, and leaves the business eighteen months behind where it should be.

VP Commercial, Sales and Marketing Directors, Regional Sales Directors. The leaders who carry quota and build the field organisation from the ground up.

Value Analysis Committees govern hospital procurement in the US. A sales leader who can't navigate a VAC process (the clinical evidence requirements, the health economics argument, the procurement timeline) can't commercialise effectively in that environment. It's a specific competency. The candidate either has it or they don't.

Republic of Ireland: HPRA approval and NCPE reimbursement submission.

Medical Affairs joins at this stage as a distinct function. KOL development, clinical advisory boards, publications strategy, and clinicalisation run separately from sales. (Companies that merge Medical Affairs into the sales function plateau at early adopter accounts. Consistently, across therapy areas.) Clinical Education and Professional Development is a further distinct hire: converting clinical interest into procedure volume is neither a sales role nor a Medical Affairs role.

Regulatory Affairs continues for post-market surveillance. For SaMD and digital health businesses, the commercial model differs materially from the device model: subscription revenue, outcome-based contracting, multi-stakeholder procurement, and Customer Success operating as a revenue protection function rather than a service function.

And whether the organisation itself is structured for what comes next.

Geographic expansion requires Channel and Distributor Management as a discipline in its own right. Managing a distributor network is a different job from managing a direct sales force, and companies that scale internationally without dedicated channel leadership consistently lose margin and market control before they understand why. US companies entering the UK or Ireland need a Managing Director with country-level P&L responsibility. That's a distinct hire. Not a promoted Regional Sales Director. Not a VP with an extended remit.

At scale, Government Affairs becomes a commercial function. CMS coverage decisions, NHS framework positioning, and legislative engagement carry direct revenue consequence and require someone who understands both the policy environment and the commercial model they're operating inside.

The leadership profile shifts here: from entrepreneurial to process-driven, from instinct to governance, from relationships to forecasting. The hire who thrived in the founding era is often the wrong hire for this phase. The right candidate has navigated this specific transition before, at a comparable company. They know which parts of the culture to protect and which parts to professionalise.

ROI commercial hires at this stage typically report into a UK or European line. The brief rarely accounts for this. It should.

Revenue is flat in a business whose product should be performing. Or the company has imported corporate leaders who understand governance but can't read the culture they've landed in. Or the founding commercial team has simply taken the business as far as their skillset allows.

Six distinct scenarios define this engagement type.

A regulatory crisis (FDA Warning Letter, consent decree, notified body suspension) requiring credible remediation leadership with a named track record of enforcement resolution, not just regulatory knowledge. Commercial underperformance in a business with proven clinical evidence and reimbursement coverage, where the commercial architecture rather than the product is the problem. A startup-to-corporate transition where founder-era leaders are brilliant at resourcefulness but can't operate a structured commercial model at scale. Post-acquisition integration: two sales forces, two pricing structures, a combined entity that needs rationalisation within ninety days before the market notices the confusion. Market access or reimbursement failure, where clearance is in hand but the payer environment hasn't opened. Geographic expansion failure, where a US commercial model has been applied to the NHS or European hospital system without adaptation.

Transformation leaders are a distinct candidate archetype. They work on eighteen to thirty-six month horizons. They're motivated by the problem, not the permanence of the role. And once the organisation is stabilised, they lose interest. The right ones know this about themselves.

Their LinkedIn profiles show multiple positions of two years or less. A generalist recruiter screens them out on tenure alone. That pattern isn't a red flag. It's the evidence that they've done this before.